Susan G. Komen
applauded a ruling of the Food and Drug Administration (FDA) to provide
accelerated approval of a new therapy to treat locally advanced or metastatic
triple-negative breast cancer (TNBC) in people whose tumors express PD-L1, as
determined by an FDA-approved test. This is the first targeted, immunotherapy
treatment available for some people with metastatic triple negative breast
cancers.

The FDA approval is
for a combination of Roche’s immunotherapy drug Tecentriq® (atezolizumab) plus
chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable
suspension (albumin-bound); nab-paclitaxel]).
The approval was based on data from the IMpassion130 trial,a randomized phase III trial designed to test whether the treatment
combination of the immune checkpoint inhibitor atezolizumab with standard
chemotherapy could improve outcomes for patients with metastatic TNBC. Results from the
study released late last year showed the combination treatment significantly
reduced the risk of the disease worsening and improved overall survival in
people with metastatic (stage IV) triple negative breast cancers that express
the PD-L1 protein.

“This is a very
exciting development as this is the first targeted immunotherapy for patients
with metastatic, triple negative breast cancer,” said Victoria Wolodzko, Susan
G. Komen’s Vice President of Mission. “This is the first of what we hope will
be many new targeted therapies that utilize the body’s own immune system to fight
breast cancer.”

The FDA’s Accelerated
Approval Program allows conditional approval of a medicine that fills an unmet
medical need for a serious or life-threatening disease or condition.Continued approval for this indication
may be contingent upon verification and description of clinical benefit in a
confirmatory trial(s).

While breast cancer
is often referred to as a single disease, there are many subtypes.Tumors that test negative for estrogen,
progesterone and HER2 receptors are called Triple
Negative Breast Cancers (TNBC).TNBC is an aggressive form of the disease that previously lacked a
targeted treatment option.Metastatic
breast cancer (also called stage IV or advanced breast cancer) is
not a specific type of breast cancer, but rather the most advanced and deadly
stage of breast cancer when it has spread beyond the breast to other organs in
the body (most often the bones, lungs, liver or brain).